[Federal Register: June 21, 2005 (Volume 70, Number 118)]
[Page 35678-35680]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0190]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Export of Food and Drug Administration Regulated 
Products--Export Certificates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements imposed on firms that intend to export to countries that 
require an export certificate as a condition of entry for FDA regulated 
products, pharmaceuticals, biologics, and devices as indicated in the 
Federal Food, Drug, and Cosmetic Act (the act), as amended.

DATES: Submit written or electronic comments on the collection of 
information by August 22, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Export of FDA Regulated Products--Export Certificates (OMB Control 
Number 0910-0498)

    In April 1996 a law entitled ``The FDA Export Reform and 
Enhancement Act of 1996'' amended sections 801(e) and 802 of the act 
(21 U.S.C. 381(e) and 382). It was designed to ease restrictions on 
exportation of unapproved pharmaceuticals, biologics, and devices 
regulated by FDA. Section 801(e)(4) of the act provides that persons 
exporting certain FDA-regulated products may request that FDA certify 
that the products meet the requirements of sections 801(e) or 802 or 
other requirements of the act. This section of the law requires that 
FDA issue certification within 20 days of receipt of the request and 
charge firms up to $175 for the certifications.
    This new section of the act authorizes FDA to issue export 
certificates for regulated pharmaceuticals, biologics, and devices that 
are legally marketed in the United States, as well as for 
pharmaceuticals, biologics, and devices that are not legally marketed, 
but are acceptable to the importing country as specified in sections 
801(e) and 802 of the act. FDA has developed five types of certificates 
that satisfy the requirements of section 801(e)(4)(B) of the act: (1) 
Certificates to Foreign Governments, (2)

[[Page 35679]]

Certificates of Exportability, (3) Certificates of a Pharmaceutical 
Product, (4) Nonclinical Research Use Only Certificates, and (5) 
Certificates of Free Sale. Table 1 of this document lists the different 
certificates and details their uses:

                                                    Table 1.
                       Type of Certificate                                              Use
``Supplementary Information Certificate to Foreign Government      For the export of products legally marketed
 Requests''                                                         in the United States.
``Exporter's Certification Statement Certificate to Foreign
``Exporter's Certification Statement Certificate to Foreign
 Government (For Human Tissue Intended for Transplantation)''
``Supplementary Information Certificate of Exportability           For the export of products not approved for
 Requests''                                                         marketing in the United States (unapproved
``Exporter's Certification Statement Certificate of                 products) that meet the requirements of
 Exportability''                                                    sections 801(e) or 802 of the act.
``Supplementary Information Certificate of a Pharmaceutical        Conforms to the format established by the
 Product''                                                          World Health Organization and is intended
``Exporter's Certification Statement Certificate of a               for use by the importing country when the
 Pharmaceutical Product''                                           product in question is under consideration
                                                                    for a product license that will authorize
                                                                    its importation and sale or for renewal,
                                                                    extension, amendment, or review of a
``Supplementary Information Nonclinical Research Use Only          For the export of a nonclinical research use
 Certificate''                                                      only product, material, or component that is
``Exporter's Certification Statement Nonclinical Research Use       not intended for human use which may be
 Only''                                                             marketed in, and legally exported from the
                                                                    United States under the act.
Certificates of Free Sale                                          For food and cosmetic products and dietary
                                                                    supplements that may be legally marketed in
                                                                    the United States.

    FDA will continue to rely on self-certification by manufacturers 
for the first three types of certificates listed in the previous 
paragraph. Manufacturers are requested to self-certify that they are in 
compliance with all applicable requirements of the act, not only at the 
time that they submit their request to the appropriate center, but also 
at the time that they submit the certification to the foreign 
    The appropriate FDA centers will review product information 
submitted by firms in support of their certificate and any suspected 
case of fraud will be referred to FDA's Office of Criminal 
Investigations for followup. Firms making or submitting to FDA false 
statements on any documents may constitute violations of 18 U.S.C. 
1001, with penalties including up to $250,000 in fines and up to 5 
years imprisonment.
    FDA estimates the burden of this collection of information as 

                                 Table 2.--Estimated Annual Reporting Burden\1\
                                  No. of       Annual Frequency   Total Annual      Hours per
         FDA Center             Respondents      per Response       Responses        Response       Total Hours
Center for Biologics                   1,501                  1           1,501        1                   1,501
 Evaluation and Research
Center for Drug Evaluation             4,803                  1           4,803        1                   4,803
 and Research
Center for Devices and                 5,674                  1           5,674        2\2\               11,348
 Radiological Health
Center for Veterinary                    664                  1             664        1                     664
Total                                 12,642  .................          12,642        .........          18,316
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
\2\ Based on center policy that allows multiple devices to appear on one certificate.

[[Page 35680]]

    Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12109 Filed 6-20-05; 8:45 am]